exosmart™ stands out from other exosome therapies due to its innovative filtration system. Designed to concentrate a broad spectrum of the body’s regenerative elements. Unlike traditional exosome therapies that focus solely on concentrating exosomes. exosmart™ is engineered to retain cells, proteins, and the fibrin network as well. This methodology is rooted in the understanding that preserving the multifaceted biological assets, inherent in the body, can lead to optimal therapeutic outcomes.

exosmart™ embraces the principle that the body’s natural healing mechanisms operate most effectively when various cellular and molecular components work in harmony. By maintaining a comprehensive representation of these biological components, exosmart™ aims to offer a more potent therapeutic impact. This is not just about isolating exosomes, but about harnessing the full range of the body’s regenerative power.

Allogeneic exosome therapies use exosomes derived from donor tissues. Which often lack additional regenerative components. This is due to the rigorous processing and storage procedures required to ensure the preservation and viability of these exosomes. Moreover, allogeneic exosomes carry an inherent risk of triggering immune reactions or rejection since they originate from another individual. exosmart overcomes these challenges by offering autologous exosomes—obtained directly from the patient’s own body. This eliminates the risk of immune reactions and ensures the vitality of the accompanying cellular components and protein activity.

exosmart™ is the only device available that is capable of procuring autologous exosomes at the point of care. While competitors might offer allogeneic exosomes, these are typically suitable only for topical applications and are subject to a rigorous regulatory process. In contrast, exosmart™ provides a versatile and practical solution that healthcare professionals can easily incorporate into their practice.

exosmart™’s ambitions go beyond merely isolating exosomes. Our goal is to tap into the full spectrum of regenerative capabilities inherent in the body’s PRP and plasma. By delivering a concentrated dose of the body’s own healing power to where it’s needed most, exosmart™ is bringing the promise of regenerative medicine to fruition.

exosmart™ embraces a comprehensive view of the body’s regenerative potential. Our technology harnesses the synergy between cellular and acellular components—exosomes, cells, proteins, and fibrin network—each contributing its unique role to the overall regenerative process. Our aim is to deliver this rich blend of regenerative elements to aid in efficient healing and tissue regeneration, truly embodying the concept of harnessing the body’s inherent healing power.

Yes, exosome usage within the EU does indeed operate under legal regulatory measures. Traditionally, exosomes have been classified as medicine due to their potent therapeutic potential. However, our product, exosmart™, falls under the category of Medical Device Class 2a. This classification is critical as it designates exosmart™ as an instrument that facilitates the acquisition of autologous exosomes from PRP and plasma at the point of care. Since the autologous products generated through exosmart™ are produced and applied during the same procedure, they aren’t subject to the same regulatory requirements as typical medicines. This model parallels the regulatory approach taken with PRP prepared within the clinic. Thus, with exosmart™, you can leverage the therapeutic power of exosomes while ensuring complete compliance with EU regulatory standards.

The current iteration of exosmart™ is optimized for use with blood PRP and Plasma. Our extensive research has elucidated the profound therapeutic potential of platelet-derived exosomes, as evidenced by the numerous supporting references shared on our website. While we acknowledge that exosomes are also present in bone marrow and adipose tissue, our first phase focuses primarily on platelet-derived exosomes. Nonetheless, these tissues can still be utilized for exosome extraction, as the device is not limited to blood-derived products. However, we do not currently provide specific protocols for these sources as our primary focus is on platelet-derived exosomes. The final product’s molecular cargo (information transferred) depends largely on the source of the exosomes and the method of isolation.

The development of exosmart™ has been an intensive two-year journey, building on the principles of our proven ProSmart technology. The critical difference lies in the device’s filtration capabilities; exosmart™ has a fine-tuned filtration cut-off of 5nm. This precision allows the device to retain exosomes in the final product during PRP and plasma processing. To operate exosmart™, you begin with 25-30ml of PRP/Plasma. This volume is gradually processed through exosmart™ until no more product remains. Following this, the air filter is opened, and the concentrate remaining in the filter is aspirated. This concentrate, about 6-8ml, is a potent mixture of cells, proteins, and exosomes, ready for therapeutic use.

Exosomes do indeed exist in PRP. However, due to their minuscule size, they tend to be diluted and typically discarded with the plasma during conventional PRP preparations. exosmart™ changes this narrative by efficiently retaining these potent vesicles during PRP processing. The usage of pure blood isn’t ideal due to the presence of red blood cells (RBCs). High concentrations of RBCs aren’t suitable for injection, and their removal via filtration is not feasible. Therefore, PRP is the preferred starting material due to its concentration of platelets and associated growth factors, minus the bulk of RBCs found in whole blood.

exosmart™ yields approximately 6-8ml of concentrated therapeutic product post-processing. This volume includes a potent blend of cells, proteins, and, importantly, several billions of exosomes per ml. This high concentration ensures a substantial payload of bioactive molecules for treatment. Regarding the leftover PRP, its handling will be contingent upon the specific procedure and volume used. If a surplus of PRP remains post-ExoSmart™ processing, it may be possible to use it in other treatments or store it appropriately for future use. This decision is at the discretion of the practitioner, taking into account factors like patient needs, treatment goals, and clinical guidelines.

The treatment depth for exosmart™ parallels the approach used in Platelet-Rich Plasma (PRP) procedures. Depending on the target area and underlying tissue, the injection may be intradermal, subcutaneous, or intramuscular. Clinical judgement determines this depth, taking into account factors such as the patient’s skin type, severity of the condition, and the intended therapeutic outcome. Remember, precision and safety are pivotal in maximizing treatment efficacy and minimizing potential side effects.

The repetition schedule for exosmart™ treatments largely depends on the patient’s physiological response and treatment objectives. Generally, subsequent sessions may be scheduled after intervals of 6, 12, or 18 months. However, a personalized treatment plan is designed after a thorough evaluation of the patient’s clinical progress. Scheduled follow-ups are essential to assess the longevity of the results and decide when a subsequent treatment may be beneficial.

As with any autologous treatment, exosmart™ follows similar contraindication profiles to PRP therapies. Certain conditions like hemodynamic instability, platelet dysfunction syndromes, critical thrombocytopenia, septicemia, and certain types of cancers could contraindicate the procedure. It’s always vital for patients to discuss their full medical history and ongoing treatments with their healthcare provider to assess suitability and risk factors associated with the therapy.

Each exosmart™ kit is designed to yield approximately 6-8 ml of autologous exosomes, adequate to treat areas of high-demand like the full face, the scalp for hair restoration or the neck for anti-aging therapies. The versatility of the exosmart™ kit allows for it to be tailor-made to address each patient’s unique needs, ensuring optimal coverage and treatment results.

Additional PRP/Plasma kits, available separately, are recommended to fully leverage the benefits of exosmart™. These kits are instrumental in generating a substantial volume (about 25-30ml) of PRP and plasma, which are laden with essential growth factors. When combined with exosmart™, the resultant therapeutic cocktail is enriched with bioactive components, paving the way for enhanced tissue regeneration and repair.

Sodium citrate serves as an anticoagulant in PRP/Plasma kits used with exosmart™, ensuring that the blood remains in a fluid state. This prevents premature clotting, enabling efficient separation of plasma and its components, particularly platelets. Subsequent processing using exosmart™ technology ensures a high yield of pure, concentrated exosomes from this platelet-rich substrate.

While the exosmart™ kit does not include test tubes, these are usually incorporated in standard PRP/Plasma kits readily available in healthcare settings. This compatibility simplifies the process, allowing practitioners to use their preferred PRP/Plasma kits alongside exosmart™, ensuring a smooth, efficient, and familiar workflow during the treatment process.

The ExoSmart system stands at the forefront of regenerative therapy, harnessing advanced ultrafiltration technology to effectively concentrate autologous platelet exosomes. While plasma naturally contains exosomes, they often exist in the upper layer in low concentrations, which may not be optimal for significant therapeutic outcomes.

Ultrafiltration in ExoSmart is key to addressing this challenge. In contrast to standard centrifugation used in many clinics, which can leave vital, smaller exosomes diluted, ExoSmart’s filtration technology precisely targets these valuable entities. With a filtration cut-off close to 15,000 KDa and an average perfusion diameter of less than 5nm, ExoSmart efficiently concentrates exosomes while filtering out smaller particles like water and fragment of salt ions.

The impact of this technology is twofold: Not only does it concentrate existing exosomes in the plasma, but it also stimulates the release of additional exosomes from the cells. This results in a rich blend of exosomes, proteins, and cells, all retained in the tubes while the unwanted components are filtered out.

A pivotal aspect of our development process, which spanned nearly two years, was identifying the optimal output volume for achieving the highest therapeutic concentrations. Starting with 25-30ml of PRP (Platelet-Rich Plasma) and PPP (Platelet-Poor Plasma), we meticulously refined the process to produce about 6ml of highly concentrated solution. This concentrated output contains approximately 5-6 billion exosomes and 800-900 platelets per ml, a testament to the efficiency of the ExoSmart system.

This concentration is not just a number; it represents a synergistic blend of exosomes with platelets, including their associated cells and proteins. Exosomes play a critical role in cellular communication and tissue repair, while platelets are fundamental in wound healing, angiogenetics properties and managing inflammation. Together, they amplify each other’s healing effects, leading to a more effective and robust therapeutic outcome.

In summary, ExoSmart elevates the concentration of exosomes and enhances their therapeutic potential by combining them with the regenerative power of platelets. This approach is the result of extensive R&D and signifies a major advancement in personalized regenerative medicine, offering a powerful solution for accelerated recovery and function restoration.

Clinical Benefits of Exosomes:

1. Cellular Communication: Exosomes play a crucial role in intercellular communication. They carry and transfer genetic information and proteins to other cells, influencing their behavior and function, which is essential in the healing process.
2. Tissue Regeneration: Exosomes can stimulate tissue repair and regeneration. They are particularly useful in promoting skin and hair follicle regeneration, making them valuable in dermatology and trichology.
3. Anti-Inflammatory Properties: Exosomes can modulate immune responses and have anti-inflammatory effects, which is beneficial in treating various inflammatory conditions.

Clinical Benefits of Cells:

1. Direct Healing Contribution: Cells such as platelets and stem cells contribute directly to the healing process by releasing growth factors and other healing agents.
2. Tissue Repair and Growth: Cells are the building blocks for tissue repair and growth. Their presence is critical in processes like wound healing, bone regeneration, and tissue repair.

Clinical Benefits of Proteins:

1. Growth Factors: Proteins, including various growth factors, play a pivotal role in healing. They stimulate cell proliferation, migration, and differentiation which are essential for tissue repair and regeneration.
2. Immune Modulation: Certain proteins have roles in modulating the immune system, helping to reduce inflammation and promote healing.

Clinical Benefits of Fibrin:

1. Supports Cellular Activities: Fibrin creates a matrix that supports cellular activities essential for healing. It acts as a scaffold where cells can adhere, grow, and migrate during the tissue repair process.
2. Hemostasis and Wound Healing: Fibrin is crucial for hemostasis (stopping bleeding) and provides a structure for the initial phases of wound healing.

Integrated Benefits of Exosomes, Cells, Proteins, and Fibrin:

• The combined use of these elements creates a synergistic effect that enhances the healing process. For example, exosomes can carry growth factors produced by cells to the injury site, while fibrin provides the necessary structure for new tissue to grow.
• This combination mirrors the natural healing process of the body, potentially leading to more effective and efficient tissue repair and regeneration.
• Utilizing all these components together can be particularly beneficial in treatments like orthopedic therapies, wound healing, cosmetic and aesthetic procedures, and in promoting overall cellular health and rejuvenation.

In summary, the integration of exosomes, cells, proteins, and fibrin offers a comprehensive approach to regenerative medicine, aligning closely with the body’s own mechanisms to optimize healing and restoration.

The timeline for observing the final results from an ExoSmart session can vary based on individual factors and the specific condition being treated. Generally, patients may start noticing improvements within a few weeks post-treatment, but it’s important to understand that the full effects might take several months to materialize fully.

In many cases, patients might observe significant results around 3 to 6 months after the session. This timeframe allows for the body to undergo natural healing and regeneration processes, aided by the concentrated exosomes, cells, proteins, and fibrin delivered through ExoSmart.

However, it’s crucial to note that each patient’s response to the therapy will differ. Factors such as the patient’s age, overall health, the severity of the condition being treated, and individual healing capabilities play a significant role in determining the speed and extent of the results.

Patients should maintain regular follow-up appointments to monitor their progress and consult with their healthcare provider to understand better their unique healing timeline and any additional care or supplementary treatments that may be required.

In each milliliter of the concentrated solution obtained from an ExoSmart session, there are approximately 5 to 6 billion exosomes. This high concentration is a result of the advanced ultrafiltration technology used in the ExoSmart system, ensuring a rich blend of exosomes for therapeutic applications.

Throughout the research and development phase of ExoSmart, several scientific studies were conducted internally to validate the technology and establish proof of concept. Following the launch of ExoSmart, its potential has garnered attention from various esteemed hospitals, universities, and clinics. These institutions have expressed interest in conducting independent, non-sponsored studies, which is a significant step toward further scientific validation.

We anticipate that within the next 18 to 24 months, we will have access to robust, double-blind, randomized clinical trial data. This upcoming research will provide a more comprehensive understanding of ExoSmart’s efficacy and applications.

In addition to these forthcoming studies, we have already received numerous anecdotal reports from day-to-day clinical use, which have been overwhelmingly positive. These real-world experiences, while not as rigorously controlled as clinical trials, offer valuable insights into the practical benefits and applications of ExoSmart in various therapeutic settings.

Proteins and cells play a crucial role in the efficacy of ExoSmart therapy, contributing significantly to the healing and regenerative outcomes.

1. Role of Proteins:
   • Growth Factors and Cytokines: Many of the proteins in ExoSmart’s concentrated solution are growth factors and cytokines. These proteins are essential for signaling cells to repair and regenerate tissue.
   • Modulating Cellular Activities: Proteins can influence various cellular activities, such as cell migration, proliferation, and differentiation, which are vital for healing and tissue repair.
   • Anti-inflammatory Action: Certain proteins have anti-inflammatory properties, helping to reduce swelling and pain at the treatment site, thereby facilitating a better healing environment.
2. Role of Cells:
   • Direct Healing Contribution: Cells, including platelets and potentially stem cells, are part of the concentrated solution. These cells directly release growth factors and other substances that aid in the healing process.
   • Tissue Regeneration: Cells are the building blocks for new tissue. They play a direct role in replacing and repairing damaged tissues, whether it’s skin, muscle, or bone.
   • Enhanced Healing Response: The presence of these cells can enhance the body’s natural healing response, making the repair process more efficient and effective.

In summary, the proteins and cells in the ExoSmart solution work synergistically to create an optimal healing environment. Proteins provide the necessary signals and biochemical tools for tissue repair, while cells directly contribute to the formation of new tissues and the healing process. This combination makes ExoSmart a powerful tool for regenerative therapies.